A study of cannabidiol (GWP42003-P, CBD) in patients with tuberous sclerosis complex who experience seizures.

Phase 1

• Conditions: Tuberous Sclerosis Complex (TSC); MedDRA version: 20.0Level: PTClassification code 10045138Term: Tuberous sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2015-002154-12-NL
• Lead Sponsor: GW Research Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-17
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Patient is male or female aged between one and 65 years
inclusive.
• Patient and/or parent(s)/legal representative is willing and able
to give informed consent/assent for participation in the study.
• Well-documented clinical history of epilepsy which is not completely controlled by their current AEDs.
• Clinical diagnosis of TSC according to criteria agreed by the 2012 International Tuberous Sclerosis Complex Consensus Conference.
• Taking one or more AEDs at a dose which has been stable for at least four
weeks prior to screening.
• All medications or interventions for epilepsy (including ketogenic diet and any neurostimulation devices for epilepsy) must have been stable for one month prior to screening and the
patient is willing to maintain a stable regimen throughout the study.
At the end of the baseline period patients must also meet the
following criterion:
• Completed at least 90% of calls to IVRS during the first
28 days of the baseline period (a minimum of 25 completed calls).
Are the trial subjects under 18? yes
Number of subjects for this age range: 94
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 116
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patient has a history of pseudo-seizures.
• Patient has undergone general anesthetic in the four weeks prior to screening or randomization.
• Patient has undergone surgery for epilepsy in the six months prior to screening.
• Patient is being considered for epilepsy surgery or any procedure involving general anesthesia during the blinded phase of the study.
• Patient has been taking felbamate for less than one year prior to screening.
• Patient is taking an oral (mTOR) inhibitor.
• Patient is currently using or has in the past used recreational or medicinal cannabis, or cannabinoid-based medications, within the three months prior to screening and is unwilling to abstain for the duration for the study.
• Patient has tumor growth which, in the opinion of the Investigator, could affect the primary endpoint.
• Patient is female and of child bearing potential, or is male whose partner is of child bearing potential, unless willing to
ensure that they or their partner use a highly effective method of birth control (e.g., hormonal contraceptives, intrauterine devices/hormone-releasing systems, bilateral tubal occlusion, vasectomized partner, sexual abstinence) during the study and for three months thereafter.
• Female patient who is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the study and for three months thereafter.
• Patient has received an IMP less than 12 weeks prior to the screening visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified